MAUDE Adverse Event Report: GYRUS ACMI, INC PKS DISSECTOR,33CM 9-PIN (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 942005PK

Device Problems Melted (1385); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Burn, Thermal (2530)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been received by olympus for evaluation.The definitive cause of the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an unspecified procedure using a dissecting forceps, the end of the sheath melted during the procedure.The patient experienced a thermal injury (burn) to the inside of the ovary.The customer stated there is no additional information available regarding the patient or event.

Manufacturer Narrative

Physical evaluation of the complaint device reveals: observed dried residue on the jaw portion of the device, that is consistent with use.The handle section, cord, connector side of the cord and shaft, all appear normal.There are light scratches and nicks on the shaft insulation; however, no metal exposure, asides from the opening for the jaw links at the distal end side; which is normal.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: warning: excessive generator output time or generator output level may result in burning tissue not intended for coagulation.Warning: the device tip may remain hot enough to cause burns after electrosurgical current is deactivated.Conclusion: although this complaint has been reported as an adverse event, evaluation of the returned device could not confirm the reported phenomenon, therefore the burn experienced was likely not a result of the melting of the distal end.

• Brand Name: PKS DISSECTOR,33CM 9-PIN (5/PK)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10888373
• MDR Text Key: 218177028
• Report Number: 3011050570-2020-00155
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K031080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 942005PK
• Device Lot Number: FR824829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other